@article {8513, title = {Effect of Early Versus Late Azathioprine Therapy in Pediatric Ulcerative Colitis.}, journal = {Inflamm Bowel Dis}, volume = {22}, year = {2016}, month = {2016 Jul}, pages = {1647-54}, abstract = {

BACKGROUND: We aimed at describing the efficacy of azathioprine (AZA) in pediatric ulcerative colitis, comparing the outcomes of early (0-6 months) versus late (6-24 months) initiation of therapy.

METHODS: Children with ulcerative colitis treated with AZA within 24 months of diagnosis were included. Corticosteroid (CS)-free remission and mucosal healing (MH), assessed by endoscopy or fecal calprotectin, at 12 months were the primary outcomes. Patients were also compared for CS-free remission and MH, need for treatment escalation or surgery, number of hospitalizations, and adverse events during a 24-month follow-up.

RESULTS: A total of 121 children entered the study (median age 10.5 {\textpm} 4.0 years, 59\% girls). Seventy-six (63\%) started AZA between 0 and 6 months (early group) and 45 (37\%) started between 6 and 24 months (late group). Seventy-five percent and 53\% of patients in the early and late group, respectively, received CS at the diagnosis (P = 0.01). CS-free remission at 1 year was achieved by 30 (50\%) of the early and 23 (57\%) of the late patients (P = 0.54). MH occurred in 37 (37\%) patients at 1 year, with no difference between the 2 groups (33\% early, 42\% late; P = 0.56). No difference was found for the other outcomes.

CONCLUSIONS: Introduction of AZA within 6 months of diagnosis seems not more effective than later treatment to achieve CS-free remission in pediatric ulcerative colitis. MH does not depend on the timing of AZA initiation; however, because of the incomplete comparability of the 2 groups at the diagnosis and the use of fecal calprotectin as a surrogate marker of MH, our results should be further confirmed by prospective studies.

}, issn = {1536-4844}, doi = {10.1097/MIB.0000000000000828}, author = {Aloi, Marina and D'Arcangelo, Giulia and Bramuzzo, Matteo and Gasparetto, Marco and Martinelli, Massimo and Alvisi, Patrizia and Illiceto, Maria Teresa and Valenti, Simona and Distante, Manuela and Pellegrino, Salvatore and Gatti, Simona and Arrigo, Serena and Civitelli, Fortunata and Martelossi, Stefano} } @article {7708, title = {Effect of Thalidomide on Clinical Remission in Children and Adolescents with Ulcerative Colitis Refractory to Other Immunosuppressives: Pilot Randomized Clinical Trial.}, journal = {Inflamm Bowel Dis}, volume = {21}, year = {2015}, month = {2015 Aug}, pages = {1739-49}, abstract = {

BACKGROUND: In a randomized controlled trial, thalidomide has shown to be effective in refractory Crohn{\textquoteright}s disease in children. This pilot study aimed at evaluating thalidomide in refractory pediatric ulcerative colitis (UC).

METHODS: Double-blind, placebo-controlled randomized clinical trial on thalidomide 1.5 to 2.5 mg/kg/day in children with active UC despite multiple immunosuppressive treatments. In an open-label extension, nonresponders to placebo received thalidomide for an additional 8 weeks; all responders were followed up for a minimum of 52 weeks.

RESULTS: Twenty-six children with refractory UC were randomized to thalidomide or placebo. Clinical remission at week 8 was achieved by significantly more children treated with thalidomide {10/12 (83.3\%) versus 2/11 (18.8\%); risk ratio, 4.5 (95\% confidence interval [CI], 1.2-16.4); P = 0.005; number needed to treat, 1.5}. Of the nonresponders to placebo who were switched to thalidomide, 8 of 11 (72.7\%) subsequently reached remission at week 8 (risk ratio, 4.0 [95\% CI, 1.1-14.7]; number needed to treat, 2.45; P = 0.01). Clinical remission in the thalidomide group was 135.0 weeks (95\% CI, 32-238), compared with 8.0 weeks (95\% CI, 2.4-13.6) in the placebo group (P < 0.0001). Cumulative incidence of severe adverse events was 3.1 per 1000 patient-weeks. Peripheral neuropathy and amenorrhea were the most frequent adverse events.

CONCLUSIONS: In this pilot randomized controlled trial on cases of UC refractory to immunosuppressive therapy, thalidomide compared with placebo resulted in improved clinical remission at 8 weeks of treatment and in longer term maintenance of remission. These findings require replication in larger clinical studies evaluating both thalidomide efficacy and safety.

}, issn = {1536-4844}, doi = {10.1097/MIB.0000000000000437}, author = {Lazzerini, Marzia and Martelossi, Stefano and Magazz{\`u}, Giuseppe and Pellegrino, Salvatore and Lucanto, Maria Cristina and Barabino, Arrigo and Calvi, Angela and Arrigo, Serena and Lionetti, Paolo and Lorusso, Monica and Mangiantini, Francesca and Fontana, Massimo and Zuin, Giovanna and Palla, Gabriella and Maggiore, Giuseppe and Bramuzzo, Matteo and Pellegrin, Maria Chiara and Maschio, Massimo and Villanacci, Vincenzo and Manenti, Stefania and Decorti, Giuliana and De Iudicibus, Sara and Paparazzo, Rossella and Montico, Marcella and Ventura, Alessandro} } @article {1796, title = {Amenorrhea in women treated with thalidomide: report of two cases and literature review.}, journal = {Inflamm Bowel Dis}, volume = {19}, year = {2013}, month = {2013 Jan}, pages = {E10-1}, keywords = {Adolescent, Amenorrhea, Colitis, Ulcerative, Crohn Disease, Female, Humans, Review Literature as Topic, Thalidomide}, issn = {1536-4844}, doi = {10.1002/ibd.22845}, author = {Lazzerini, Marzia and Bramuzzo, Matteo and Martelossi, Stefano and Magazz{\`u}, Giuseppe and Pellegrino, Salvatore and Ventura, Alessandro} }